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��ࡱ�>��	BD����?@A���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������bjbjOO*-a-aIl+�������iiiii����}}}8��9�})���(���7(9(9(9(9(9(9($�*�R-
](ii�����](ii��(~$~$~$��ii7(~$�7(~$~$?'g'�����[��#L������!W'#(�(0)_'\.�!n\.g'\.ig'�~$���](](V$(���)������������������������������������������������������������������������\.���������!/:Development and Validation of a Prognostic Index for Early Mortality after Aortic Valve Replacement


Emiliano Angelon, Giovanni Melina, Simone Refice, Antonino Roscitano, Fabio Capuano, Cosimo Comito, Riccardo Sinatra.

Department of Cardiac Surgery, �Sapienza� University of Rome, Policlinico Sant�Andrea, Rome, Italy.



Word count: 4097




Corresponding Author:
Emiliano Angeloni, MD
Sapienza, University of Rome
Dept. of Cardiac Surgery, Ospedale Sant�Andrea
Via di Grottarossa 1035, 00189 Rome (I)
Tel: +390633775593; Fax: +390633776413
e-mail:  HYPERLINK "mailto:emilianoangeloni@gmail.com" emilianoangeloni@gmail.com
e-mail: emiliano.angeloni@uniroma1.itAbstract
Background. The availability of new techniques and an aging patient population are the main issues which drive careful patient selection for aortic valve replacement (AVR). The widely used EuroSCORE has been recently reported to be unreliable for aortic valve surgery. In these settings, a simple clinical tool for assessing the surgical risk would enable more accurate decision-making.
Methods. Consecutive patients that underwent AVR were reviewed. Variables independently associated with 30-day mortality were tested by means of multivariate logistic regression and a score-index was generated. A different series of patients who underwent AVR were used as validation cohort. The predictive power of the model was assessed with Receiver operating characteristic (ROC) curve analysis and Hosmer-Lemeshow analysis.
Results. The development cohort consisted of 740 patients (40%female; mean age 71�11years). Thirty-day mortality was 25/740(3.4%). Among the variables studied, preoperative critical state(p=0.02;OR:2.52), aortic annular diameter<23mm(p=0.03;OR:2.61) and previous cerebro-vascular accident (p=0.02;OR:4.97) were independently correlated to 30-day mortality and were used to compound a risk model. When applied to the validation cohort our prognostic index resulted in a mean score of 1.08�0.53 in dead and 0.62�0.12 in survivors (p<0.0001). The ROC curve analysis showed an excellent predictive power for this prognostic index (AUC 0.84; p=0.0001), slightly better than logistic EuroSCORE (AUC 0.82).
Conclusions. Preoperative critical state, aortic annular diameter and previous cerebro-vascular accident were identified as major risk factors which correlated with early mortality after AVR. A simple and reliable point-score index was developed and showed a predictive power similar to EuroSCORE.
Word count: 250Introduction

Aortic valve replacement (AVR) is a common operation in cardiac surgery with aortic stenosis (AS) being the most common heart valve disease in the elderly [1]. According to the latest report from the Society of Thoracic Surgeons database [2], most patients requiring aortic valve surgery are affected by AS and some degree of coronary artery disease (CAD) is common. Therefore, AVR has become one of the commonest cardiac surgical procedures required after coronary artery bypass grafting (CABG) [3-5].
Because of the increasing number of elderly patients and the hightened expectations associated with trans-cutaneous procedures [6], early outcome after AVR has become a matter of great interest. Recently, the widely used European System for Cardiac Operative Risk Evaluation (EuroSCORE) [7] has been reported to provide over-prediction of procedural risk in patients undergoing transcatheter aortic valve implantation and doubts aroused about its predictive value and accuracy when estimating risk in patients with aortic valve disease, especially in the elderly [8-13]. Many authors have investigated early results after isolated or complex AVR [2,4,5]; reporting female sex, older age and lower left ventricular ejection fraction (LVEF) as the main risk factors related to early mortality [2]. Risk models were developed [4,5] to identify to identify the main risk factors and to generate scores which turned out to be more reliable and accurate than EuroSCORE when applied to AVR patients [4,5]. However, the development of such scores [4,5] has been undertaken on split cohorts of patients and has failed to provide a simple and convenient clinical tool. Against this background and the recent update of guidelines from America College of Cardiology/American Heart Association Joint Committee [3], surgeons and cardiologists remain uncertain about operative risk which frustrates the consent process. Aim of the present study is the development of a reliable and accurate prognostic score index that should also be a simple, robust, easy-to-use clinical tool to assess the surgical risk in AVR patients.
The building of such a score is not meant just for fastness, but moves its reasons from general advice of statisticians to be parsimonious, because it is preferable to use only the few variables know to be the most powerful predictors [14-18] instead of many more. According to that �law of parsimony� stated by Wells and colleagues [15] as �less is more in multivariable analysis�; we developed a prognostic index based upon only 3 variables, not subject to vary because of personal interpretation.
Materials and Methods

Patients and variables
Consecutive patients who underwent AVR (isolated or concomitant with other cardiac procedures) between May 2004 and October 20014 were reviewed to generate the development cohort. Development and validation cohort were randomly obtained picking the same number of patients operated on each year.
Patients received either a mechanical or biological prosthesis (Carpentier-Edwards Perimount Magna, Edwards Lifesciences LLC, Irvine, CA; Carbomedics Standard Aortic Valve, Carbomedics Inc., Austin, TX or St. Jude Medical HP Series, St. Jude Medical, St. Paul, MN). All aortic valve prostheses were inserted in a supra-annular fashion using interrupted 2-0 simple sutures.
We considered as potential predictors of mortality demographic variables as age and sex and preoperative functional status and comorbidity variables such as aortic disease aetiology, New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) functional classes, CAD, number of coronary vessels with significant disease, LVEF, LV mass index, aortic anteroposterior annular diameter, aortic transvalvular pressure gradient, diabetes, hypercholesterolemia, body mass index (BMI), chronic obstructive pulmonary disease (COPD), heart rhythm disorders, previous CVA, previous myocardial infarction, peripheral vascular disease, previous cardiac surgery, critical preoperative state, year of the operations and operating surgeon.
Multicollinearity of the model was checked with a tolerance and inflation statistics. Linearity assumption was checked with graphical plotting of logit log-linear regression.
For aortic aetiology there were five possible classes: degenerative, endocarditis, rheumatic, aortic root dilatation and prosthetic valve failure.
The patients were classified as being in a critical preoperative state if they had experienced one or more of the following: ventricular tachycardia or fibrillation, aborted sudden death, preoperative cardiac massage, preoperative ventilation before arrival in the anaesthetic room, preoperative inotropic support, intra-aortic balloon pump conterpulsation or preoperative acute renal failure (anuria or oliguria less than 10mls/h).
As in most cardiac surgery units, those patients, both in development and validation cohorts, with a history of smoking or bronchodilator usage and those with respiratory symptoms such as chronic cough and sputum production were tested by spyrometry before operation. A patient was diagnosed having COPD when the forced expiration volume in one second was less than 80% of normal predicted value (for his individual age, gender, height and weight) and the ratio to forced vital capacity was less than 0.7 [19].

Preoperative echocardiographic evaluation
Left ventricular mass was calculated according to the European and American Associations of Echocardiography guidelines [20] and normalized by height2.7 [21]. LV volumes were estimated using the z-derived method [22] and LVEF was calculated as (end diastolic volume � end systolic volume)/end diastolic volume. Anteroposterior diameter of the aortic annulus was assessed using transthoracic echocardiography. In the absence of a world wide tool recognized as gold standard for this measurement, recent papers [23] reported no significant differences between measurements performed by means of trans-thoracic or trans-oesophageal echocardiography or multi-slice computed tomography. The mean gradient was measured by use of continuous-wave Doppler echocardiography and the simplified Bernoulli equation. All Doppler measurements were obtained as the average of at least 3 cycles in patients with sinus rhythm or more than 5 cycles in those with atrial fibrillation.

Statistical analysis
Using 30-day mortality as the dichotomous outcome variable, we measured the bivariable relationship between each of the 25 risk factors (Table 1) and mortality. A relative risk analysis for categorical binary data and a Student t test for unpaired data for continuous variables were performed. A Bonferroni correction to avoid errors due to multiple comparison was applied. Eleven of those variables were found to be significant predictors of early mortality and we sought to analyze them by means of a Receiver operating characteristic (ROC) curve analysis, using the Area under the curve (AUC) as an accuracy index. The 3 variables showing the best AUC were forced in a subsequent multivariable logistic regression analysis and its coefficients were used to compound a risk score. Calibration of the final model was checked using Hosmer-Lemeshow goodness-of-fit test, which showed the absence of a gross lack of fit (p=0.29).
A point-based risk scoring system was developed. Points were assigned to each risk factor by dividing each � coefficient by the lowest � coefficient (ability to push or pull heavy objects) and rounding to the nearest integer. A risk score was assigned to each participant by adding the points for each risk factor present.
The validation cohort was chosen to be geographically distinct from our development cohort to test our model�s geographic transportability as well as our model�s accuracy. We assessed the predictive accuracy of the final model by looking at discrimination calculating the ROC curve. Comparison with logistic EuroSCORE was made dividing the population into quartiles of risk each including H"121 patients. Predicted and observed mortality rates for each risk class were estimated and compared.
 Statistical analysis were performed using the Statistical Package for the Social Sciences, version 11 (SPSS, Chicago, IL). 
Results

Baseline characteristics
The development cohort consisted of 740 patients (40% female; mean age 71�11 years). Baseline characteristics are depicted in Table 1. The majority underwent surgery because of aortic stenosis (n=536, 73%), CAD was present in 295 (40%) of patients and 30-day mortality was 25/740 (3.4%).
The validation cohort consisted of 485 patients (37% female; mean age 72�9 years). Likewise, most of these patients underwent surgery because of AS (n=373, 77%), CAD was present in 203 (42%) patients and 30-day mortality was 19/485 (3.9%).
The validation cohort showed lower rates of previous CVA and peripheral vascular disease, perhaps due to the lower percentage of diabetics (15.8% vs. 17.3%; p=0.54) and hypercolesterolemic (43.9% vs. 52.7%, p=0.003). Of note, the validation cohort consisted of a smaller number of redo procedures (9.5% vs. 13.4%, p=0.04) and hence showed a lower incidence of prosthetic valve failure among aortic disease aetiology (2.9% vs. 7%, p=0.002). Furthermore, isolated AVR accounted for 55% of the development cohort and 51% of patients from the validation cohort. In the end, the validation cohort showed a lower mean aortic annular diameter (21.7�2.2 mm vs. 24.2�2.3 mm, p<0.0001). This may be explained by the differences in body surface area (1.87�0.52 m2 vs. 2.06�0.33 m2, p<0.0001) and body mass index (25.8�11 vs. 27.5�10.8, p=0.007) between cohorts.

Development of the prognostic score-index
Among the above listed 23 variables investigated, only even showed some correlation to 30-day mortality at univariate analysis: age (AUC 0.65; p=0.04), female sex (AUC 0.54; p=0.04), BMI (AUC 0.59; p=0.01), preoperative CCS class>2 (AUC 0.66; p=0.0001), NYHA class>2 (AUC 0.66; p=0.001), COPD (AUC 0.6; p=0.03), CVA (AUC 0.67; p=0.002), preoperative LVEF<50% (AUC 0.66; p=0.001), critical preoperative state (AUC 0.68; p=0.0007), number of diseased coronary vessels (AUC 0.51; p=0.03) and aortic annular diameter<23 mm (AUC 0.67; p=0.002).
Categorical variables such as NYHA and CCS classes were dichotomized on the basis of the ROC analysis: both showed a better predictive power criterion when >2. Preoperative LVEF and aortic annular diameter as well were categorized on the basis of ROC curve analysis. In the final model those variables were entered as NYHA class>2, CCS class>2, LVEF<50% and aortic annular diameter<23 mm; which were the classes showing the best predictive power at ROC curve analysis.
Among the eleven variables founded independently correlated to 30-day mortality, the three showing the better AUC were previous CVA, preoperative critical state and aortic annular diameter. At multivariate logistic regression, the correlation coefficients of such risk factors were used to generate a point-based risk score index (0-3 points, Table 2).
When applied to our cohort of patients (Table 3), mean scores were 1.01�0.31 in dead and 0.59�0.11 in survivors; difference between was found statistically significant (p<0.0001).

Validation of the prognostic index
When the point-score index was applied to the validation cohort (Table 3), a statistically significant difference was found between dead and survivors: 1.08 � 0.53  vs. 0.62 � 0.12, respectively; p<0.0001. 
The calibration of the model was good, with close agreement between observed and expected mortality (10 classes, always <40%), Hosmer-Lemeshow statistics: 8 degrees of freedom; (2 6.09; p=0.64.
The final model was tested by means of a ROC curve analysis and showed a good predictive power for this prognostic index: AUC 0.84; 95%CI 0.78 to 0.89; p=0.0001. A score index of 2 or 3 points was found to predict early mortality after AVR with 90% Specificity and 73% Sensitivity.

Comparison with Additive and Logistic EuroSCORE
The validation cohort was also used to compare the predictive power of both additive and logistic EuroSCORE to our prognostic index. Mean logistic EuroSCORE was 9.36�11.1% and mean additive EuroSCORE was 7.41�3.4 points. ROC curve analysis (AUC 0.82, 95%CI 0.78 to 0.86, p=0.0001) showed a logistic EuroSCORE<11.3% to predict 30-day mortality with 77% Sensitivity and 79% Specificity. Additive EuroSCORE showed a similar predictive power (AUC 0.8, 95%CI 0.75 to 0.84, p=0.0001) and was found to predict early mortality with 92% Sensitivity and 60% Specificity when >7 points.
The slightly better accuracy demonstrated by our index in predicting early mortality was compared to EuroSCORE in each risk quartile in terms of difference between observed and predicted mortality rates (Table 4). Predicted mortality rates provided by our score-point index were closer to observed values than those provided by logistic EuroSCORE, but that difference was not found statistically significant.Discussion

The objective of a prognostic index is to provide accurate predictions when used on a new sample of patients. Thus the system should remain accurate when applied to a group of patients who where not included in its development but who are from a similar population or in patients drawn from a different but related population or in data collected by using methods that differ from those used in development [26]. Therefore, to be reliable, a prognostic index has to be generalizable.
We chose to develop our score using a heterogeneous population built-up of patients undergoing AVR with or without CABG or other cardiac procedures. On the other hand, to avoid bias related with prosthetic valve performance (in terms of hemodynamic performance and durability) we enrolled patients receiving different types of aortic prostheses; aiming to generate a reliable prognostic index that satisfies reproducibility and transportability requirements.
Developing our risk model, we found three main risk factors related to early mortality after AVR: preoperative critical state, aortic annular diameter smaller than 23 mm and past medical history positive for CVA. Of note, supporting the excellent results recently reported in literature after surgery in octogenarians [9], older age was found to be independently correlated with early mortality, but not enough to enter the top three variables finally used to compound the model.
Our prognostic index was developed using more AVR-targeted variables such as LVMi, transvalvular pressure gradient and aortic annular diameter, which stratify patients for the degree of aortic disease and correct other common risk factors for aortic-specific conditions. In these settings, beside classical risk factors for mortality such as critical preoperative state, our prognostic index identified aortic annular diameter as the aortic disease-related factor with the greatest impact on survival. Because a smaller aortic annular diameter is obviously correlated to a high risk of patient-prosthesis mismatch (PPM) after surgery, this unfavourable effect of a smaller aortic annulus can be explained by the functional impairment and adverse outcome associated with the occurrence of PPM after AVR [24].
A past medical history positive for CVA indicates some degree of cerebrovascular disease, which may be a surrogate for hypertension and atherosclerosis disease in other beds, such as the the coronary vasculature and this may in turn correlate with continued ventricular dysfunction and persistent hypertension [25] which are conditions well-known to be correlated with surgical mortality.
Once developed, our prognostic index was tested and validated using a cohort that satisfies generalizability criteria as it is a cohort of different patients with different risk factors� distribution. Development and validation cohorts differed also in their composition, because of the presence in the validation cohort of two different types of tissue prosthesis as well as mechanical prosthesis. Despite these differences between cohorts, our risk model showed a statistically significant power in predicting 30-day mortality after surgery when applied to the validation cohort. The statistical performance of our model in the heterogeneous validation cohort provides evidence of its accuracy, reliability and generalizability. Compared to both additive and logistic EuroSCORE it showed a slightly greater predictive power which was not found to be statistically significant but testifies how our simpler system achieves similar accuracy. Other models [4,5], have already been found reliable and accurate in the past, but were more complex and difficult to use. Our model, based upon only three, is easily available to the clinician as a bed-side tool and gives a score from 0 to 3 points that quickly identifies the surgical risk of the patient. Thus, our prognostic index configures not only as an accurate risk model but also as a straightforward tool that can help the clinician in decision making in patients about to undergo aortic valve replacement.
References
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Table 1. Baseline characteristics.
Development
Cohort
(n=740)Validation
Cohort
(n=485)p valueAge, years (SD)71.4 (10.9)72.4 (9.3)0.12Sex Female, n (%)297 (40.1)179 (37)0.08Body mass index, median (IQR)26.9 (6.3)25.2 (5.9)0.27Diabetes, n (%)128 (17.3)77 (15.8)0.05Hypercholesterolemia, n (%)390 (52.7)213 (43.9)0.002COPD, n (%)82 (11.1)57 (11.7)0.81CRD, n (%)26 (3.5)17 (3.5)0.94Previous CVA, n (%)43 (5.8)24 (4.9)0.43Peripheral vascular disease, n (%)39 (5.2)23 (4.7)0.36Preoperative arrhythmias, n (%)109 (14.7)68 (14)0.88Previous MI, n (%)68 (9.2)48 (9.9)0.79Previous cardiac surgery, n (%)99 (13.4)46 (9.5)0.09NYHA class>2, n (%)I12 (1.6)13 (2.7)0.12II645 (87.2)419 (86.4)0.85III60 (8.1)42 (8.6)0.76IV23 (3.1)11 (2.3)0.61CCS class>2, n (%)I372 (50.2)247 (51)0.55II252 (34.1)164 (33.8)0.58III89 (12.1)54 (11.1)0.47IV27 (3.6)20 (4.1)0.29Aortic pathology, n (%)Stenosis536 (73)373 (77)0.16Regurgitation135 (18)68 (14)0.21Mixed69 (9)44 (9)0.77Aortic aetiology, n (%)Degenerative663 (90)446 (92)0.43Endocarditic12 (1)11 (2.3)0.10Prosthetic valve failure51 (7)14 (2.9)0.0001Rheumatic8 (1)5 (1)0.99Annular-ectasia6 (1)9 (1.8)0.74Coronary artery disease, n (%)295 (39.9)203 (41.8)0.33Number of diseased coronary vessels, mean (SD)1.9 (0.9)1.9 (1)0.48Preoperative critical state, n (%)154 (20.8)61 (12.6)0.004LVEF<50%, n (%)Good (= LVEF>50%)421 (56.9)282 (58.2)0.11Moderate (= LVEF 50-30%)230 (31.1)141 (29.1)0.57Poor (= LVEF<30%)89 (12)62 (12.7)0.63LVMi, g/m2.7, mean (SD)68.6 (15.2)69.8 (18.4)0.36Trans-aortic pressure gradient, mmHg, mean (SD)78.1 (26.4)78.7 (25.7)0.59Aortic annular diameter, mm, mean (SD)24.2 (2.3)21.7 (2.2)0.81
SD, Standard deviation; IQR, Interquantile range; COPD, Chornic obstructive pulmonary disease; CRD, Chornic renal disease; CVA, Cerebro-vascular accident; MI, Myocardial infarction; NYHA, New York Heart Association; CCS, Canadian Cardiovascular Society; LV, Left ventricular; LVEF, Left ventricular ejection fraction; LVMi, Left ventricular mass index.
Table 2. Multivariable logistic regression analysis.
Variablesp value95% CIOR�
coefficientPointsPrevious CVA0.021.82 to 11.24.971.601Preoperative critical state0.021.74 to 5.852.521.311Aortic annular diameter<23mm0.031.55 to 6.432.611.251
CI, Confidence interval; OR, Odds ratio; CVA, Cerebro-vascular accident.Table 3. Stratification of mortality rates and mean Score-index in development and validation cohorts.
Development
CohortValidation
Cohort30-day Mortality, n (%)25 (3.4)19 (3.9)Mean Score in Dead, mean (95%CI)1.01 � 0.311.08 � 0.53  Mean Score in Survivors, mean (95%CI)0.59 � 0.11df������C	N	P	T	W	Y	o	�	�	�	�	�	


 
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Table 4. Observed and predicted mortality rates stratified for risk classes.
Risk Class
QuartilesObserved
Mortality, %Predicted Mortality, %p valuePoint-Score
IndexLogistic
EuroSCORE10.80.94.20.2221.61.36.10.1034.95.112.60.0847.37.214.50.10












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